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Controlled clinical trial, randomized by strata (sex and period of the study), with 6 parallel branches to the study depending on the type of product consumed and the type of physical exercise program performed, double-blind masked for the consumption of the product and single-center.
The subjects that meet the selection criteria will make a total of seven visits to the research laboratory (two of them to collect product) and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group 1 (TS + placebo) | Experimental | Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits. Daily consumption for 3 months of placebo milk. |
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| Experimental group 2 (TS + leucine) | Experimental | Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits. Daily consumption for 3 months of milk enriched with leucine. |
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| Experimental group 3 (HRC + placebo) | Experimental | Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits. Daily consumption for 3 months of placebo milk. |
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| Experimental group 4 (HRC + leucine) | Experimental | Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits. Daily consumption for 3 months of milk enriched with leucine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary supplement consumption | Dietary Supplement | Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle mass | Dual X-ray absorptiometry (DEXA) | Change of this measurement at 3 months. |
| Total fat mass | Dual X-ray absorptiometry (DEXA) | Change of this measurement at 3 months. |
| Total fat free mass | Dual X-ray absorptiometry (DEXA) | Change of this measurement at 3 months. |
| Fat free mass on upper limb | Dual X-ray absorptiometry (DEXA) | Change of this measurement at 3 months. |
| Upper limb fat mass | Dual X-ray absorptiometry (DEXA) | Change of this measurement at 3 months. |
| Fat-free mass in the lower limb | Dual X-ray absorptiometry (DEXA) | Change of this measurement at 3 months. |
| Lower limb fat mass | Dual X-ray absorptiometry (DEXA) | Change of this measurement at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Elbow extension | Upper limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power. | This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Experimental group 5 (no physical exercise + leucine) | Experimental | The subjects will not carry out any type of physical activity. Daily consumption for 3 months of milk enriched with leucine. |
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| Control (no physical exercise + placebo) | No Intervention | The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk. |
| Elbow flexion | Upper limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power. | This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end). |
| Knee extension | Lower limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power. | This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end). |
| Knee flexion | Lower limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power. | This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end). |
| Blood samples: Glycid metabolism and lipid metabolism. | Basic glucemia, total cholesterol, cholesterol HDL, cholesterol LDL, , triglycerides. | Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months. |
| Liver safety variables | It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. | Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months. |